Katalyst Healthcares & Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares & Life Sciences, San Diego, California, United States, 92189
Job Description
Job Title:
Regulatory Affairs SpecialistCompany:
US Tech SolutionsJob type:
ContractDuration:
12 monthsID:
5175Department:
Regulatory AffairsPrerequisites:BS/BA degree in Scientific Discipline (Masters or higher preferred)A minimum of 7 years in the pharmaceutical industryA minimum of 5 years CMC regulatory (biologics preferred) experienceResponsibilities will include, but are not limited to, the following:Responsible for the development of the CMC regulatory strategy for submissions, including IND/CTA/BLA, NDA, CTD, and MAA regulatory filings.Lead the preparation and review of CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.Responsible for the management of CMC activities related to specific developmental or commercial compounds.Responsible for the regulatory evaluation of CMC change controls.Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.Take a leadership role in the CMC development/commercial teams.Maintain knowledge of the global regulatory environment, regulations, and procedures.Skills/Knowledge Required:Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses, and IND/CTAs).Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.Thorough knowledge of FDA, EMEA, and ICH guidelines.Knowledge of rest of world pre- and post-approval guidelines.Have a solution-oriented approach to problem solving.Expertise in the biologic drug development process and post-approval activities.Ability to work on complex projects and within cross-functional teams.Prior supervisor or project management experience.Experience with global CMC regulations for biological compounds.Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr
Job Title:
Regulatory Affairs SpecialistCompany:
US Tech SolutionsJob type:
ContractDuration:
12 monthsID:
5175Department:
Regulatory AffairsPrerequisites:BS/BA degree in Scientific Discipline (Masters or higher preferred)A minimum of 7 years in the pharmaceutical industryA minimum of 5 years CMC regulatory (biologics preferred) experienceResponsibilities will include, but are not limited to, the following:Responsible for the development of the CMC regulatory strategy for submissions, including IND/CTA/BLA, NDA, CTD, and MAA regulatory filings.Lead the preparation and review of CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.Responsible for the management of CMC activities related to specific developmental or commercial compounds.Responsible for the regulatory evaluation of CMC change controls.Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.Take a leadership role in the CMC development/commercial teams.Maintain knowledge of the global regulatory environment, regulations, and procedures.Skills/Knowledge Required:Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses, and IND/CTAs).Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.Thorough knowledge of FDA, EMEA, and ICH guidelines.Knowledge of rest of world pre- and post-approval guidelines.Have a solution-oriented approach to problem solving.Expertise in the biologic drug development process and post-approval activities.Ability to work on complex projects and within cross-functional teams.Prior supervisor or project management experience.Experience with global CMC regulations for biological compounds.Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr